Workstation, G2, Configured (P/N 000-0241)
FDA Recall Z-2228-2019 · Posted 2019-08-08
Recalling FirmIntellijoint Surgical, Inc.
Recall StatusTerminated
Product CodeOLO
Date Initiated2019-06-28
Date Terminated2020-09-16
Product Quantity23 units
Reason for Recall
Apple has determined that, in a limited number of older generation 15-inch MacBook Pro Units, the battery may overheat and pose a fire safety risk. To date, Intellijoint has distributed, 15-inch MacBook Pros which are the Workstation component (affected P/N 000-0241) in the Intellijoint HIP System.
Firm Action
The firm initiated the recall by email on 06/28/2019. The letter requested the distributor locate and return the MacBooks.
Root Cause
Nonconforming Material/Component
Distribution Pattern
IL, CA, NY, TX, RI, Australia
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.